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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

2026年4月22日 更新者：Zhiguang Zhou、Second Xiangya Hospital of Central South University

Prediabetes Reversion Through Combined Intervention and Strict Evaluation Trial: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study on the Efficacy of Chiglitazar Sodium Combined With Lifestyle Intervention in Restoring Normal Glucose Tolerance in Prediabetic Patients

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Chiglitazar Sodium combined with lifestyle intervention for reversing prediabetes to normal glucose metabolism. Eligible participants with prediabetes will be randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention, for 52 weeks, followed by a 12-week observation period and optional long-term extension. The primary endpoint is the reversion rate to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, glycemic control, lipid profile, blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include inflammatory markers and long-term cardiovascular outcomes. Safety endpoints include adverse events, vital signs, ECG, and laboratory parameters.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Prediabetes is an intermediate state of hyperglycemia that precedes the development of type 2 diabetes. Reversing prediabetes to normal glucose metabolism represents a promising strategy for diabetes prevention. Chiglitazar Sodium is a novel PPAR pan-agonist with potential benefits on glycemic control and metabolic parameters.

This national multicenter study will be conducted across 30 sites in China. A total of 472 participants aged 18-70 years with prediabetes (according to Chinese expert consensus criteria, including IFG, IGT or IFG+IGT) and BMI 20-32 kg/m² will be enrolled.

The study consists of four phases:

Screening Period (up to 2 weeks): Assessment of eligibility including OGTT, laboratory tests, and medical history.

Double-Blind Treatment Period (52 weeks): Eligible participants are randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention (diet and exercise according to Chinese Diabetes Prevention Guidelines). Study visits occur at weeks 4, 12, 24, 36, and 52.

Observation Period (12 weeks, weeks 53-64): Participants who have not developed diabetes enter a 12-week drug-free observation period, with final assessment at week 64.

Extension Period (up to week 156): Participants who have not developed diabetes and provide consent may continue follow-up for long-term cardiovascular outcomes assessment at weeks 104 and 156.

The primary endpoint is the proportion of participants achieving reversion to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, changes in fasting plasma glucose, OGTT (1h/2h PPG), HbA1c, lipid profile (TG, TC, LDL-C, HDL-C), blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include changes in inflammatory markers (hsCRP, IL-6, TNF-α) and incidence of heart failure, non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or all-cause death through week 156. Safety will be monitored throughout.

研究类型

介入性

注册 (估计的)

472

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Beijing、中国
        • Xuanwu Hospital Capital Medical University
        • 接触：
        • 首席研究员：
          • YU Sun, MD, PhD
      • Beijing、中国
        • Beijing Tsinghua Changgung Hospital
        • 接触：
      • Beijing、中国
        • Emergency General Hospital
        • 接触：
          • Kailiang Wang, MD, M.M.
          • 电话号码：+861087935595
          • 邮箱：ht15s@163.com
      • Chongqing、中国、400038
        • The Southwest Hospital of the Army Medical University
        • 接触：
        • 首席研究员：
          • Min Long, MD, PhD
      • Shanghai、中国
        • Shanghai Ninth People's Hospital
        • 接触：
      • Shanghai、中国
        • Tongji Hospital of Tongji University
      • Shenzhen、中国
        • Shenzhen Bao'an People's Hospital
        • 接触：
          • Jisu Xue, MD, PhD
          • 电话号码：+8675527783061
          • 邮箱：baxjs@126.com
      • Shenzhen、中国
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital
        • 接触：
    • Fujian
      • Quanzhou、Fujian、中国
        • Quanzhou First Hospital, Fujian
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国
        • The First Affiliated Hospital of Guangzhou Medical University
        • 接触：
          • Xiaoyan Chen, MD, PhD
          • 电话号码：+862083062114
          • 邮箱：gzscxy@126.com
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150086
        • The Second Affiliated Hospital of Harbin Medical University
        • 接触：
        • 首席研究员：
          • Hong Qiao, MD, PhD
      • Harbin、Heilongjiang、中国、150010
        • The First Hospital of Harbin
        • 接触：
        • 首席研究员：
          • Binhua Xu, MD, M.M.
    • Henan
      • Luoyang、Henan、中国
        • The First Affiliated Hospital of Henan University of Science & Technology
        • 接触：
    • Hubei
      • Wuhan、Hubei、中国、430071
        • Zhongnan Hospital of Wuhan University
        • 接触：
          • Zhe Dai, MD, PhD
          • 电话号码：+862767812787
          • 邮箱：betamm@163.com
        • 首席研究员：
          • Zhe Dai, MD, PhD
    • Hunan
      • Changde、Hunan、中国
        • The First People's Hospital of Changde City
        • 接触：
      • Changsha、Hunan、中国
        • The Third XIANGYA Hospital of Central South University
        • 接触：
      • Changsha、Hunan、中国
        • People's Hospital of Hunan Province
        • 接触：
      • Changsha、Hunan、中国、410011
        • The Second Xiangya Hospital, Central South University
        • 首席研究员：
          • Zhiguang Zhou, MD, PhD
        • 接触：
        • 副研究员：
          • Chuqing Cao, MD, PhD
      • Changsha、Hunan、中国
        • Changsha Eighth Hospital
        • 接触：
      • Loudi、Hunan、中国
        • Loudi Central Hospital
        • 接触：
          • Weiping Sun, MD, PhD
          • 电话号码：+867388527739
          • 邮箱：sunwp07@163.com
      • Xiangtan、Hunan、中国
        • The Central Hospital of Xiangtan
        • 接触：
      • Yongzhou、Hunan、中国
        • The Central Hospital of Yongzhou
        • 接触：
      • Yueyang、Hunan、中国
        • Yueyang People's Hospital
        • 接触：
          • Dijun Zhou, MD, PhD
          • 电话号码：+867308725393
          • 邮箱：Z121300@126.com
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • Sir Run Run Hospital, Nanjing Medical University
        • 接触：
    • Shanxi
      • Changzhi、Shanxi、中国
        • Heji Hospital Affiliated to Changzhi Medical College
        • 接触：
    • Sichuan
      • Chengdu、Sichuan、中国、610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • 接触：
        • 首席研究员：
          • Limin Tian, MD,PhD
      • Chengdu、Sichuan、中国、610036
        • The Third People's Hospital of Chengdu
        • 接触：
        • 首席研究员：
          • Xiaowei Zhong, MD,PhD
      • Chengdu、Sichuan、中国、610499
        • Chengdu First People's Hospital
        • 接触：
        • 首席研究员：
          • Lin Pu, MD,M.M.
    • Yunnan
      • Kunming、Yunnan、中国
        • The First Affiliated Hospital of Kunming Medical University
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

1.Voluntarily signed informed consent. 2. Age 18 to 70 years, inclusive. 3. Diagnosed with prediabetes according to the Chinese expert consensus on intervention for adults with pre-diabetes (2023 edition), meeting any of the following criteria:

  1. Impaired fasting glucose (IFG): fasting plasma glucose (FPG) ≥ 6.1 mmol/L and < 7.0 mmol/L, with 2-hour postprandial glucose (2hPG) < 7.8 mmol/L and HbA1c < 6.5%
  2. Impaired glucose tolerance (IGT): FPG < 6.1 mmol/L, with 2hPG ≥ 7.8 mmol/L and < 11.1 mmol/L, and HbA1c < 6.5%
  3. IFG + IGT, with HbA1c < 6.5%
  4. HbA1c 5.7% to 6.4% (inclusive), with FPG and OGTT 2hPG not meeting diabetes diagnostic criteria 4. Body Mass Index (BMI) 20-32 kg/m². 5. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  1. Use of glucose-lowering medications within 3 months prior to screening.
  2. Major cardiovascular or cerebrovascular events within 6 months prior to screening, defined as:

1)Acute myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, severe arrhythmias (e.g., ventricular fibrillation, atrial flutter, atrial fibrillation, etc.), unstable angina, transient ischemic attack, ischemic stroke, or hemorrhagic stroke 2)New York Heart Association (NYHA) class III or IV congestive heart failure 3)Current use of loop diuretics or digitalis 3.Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite treatment, or use of three or more antihypertensive agents with inadequate control (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg).

4.eGFR ≤ 15 mL/min/1.73 m² (CKD-EPI Creatinine Equation 2021). 5.Urinary albumin-to-creatinine ratio (UACR) > 300 mg/g. 6.Hemoglobin < 110 g/L. 7.Fasting triglycerides > 5.6 mmol/L (500 mg/dL). 8.Active liver disease or significant hepatic dysfunction, defined as AST > 2.5×ULN and/or ALT > 2.5×ULN and/or total bilirubin > 1.5×ULN.

9.Severe pulmonary disease with treatments that may potentially affect glucose metabolism (e.g., inhaled corticosteroids, beta-agonists).

10.History of acute or chronic pancreatitis, or history of gallbladder or bile duct disease (except post-cholecystectomy for gallstones or cholecystitis).

11.Gastrointestinal disorders affecting gastric emptying, such as gastroparesis, postoperative gastric stasis, idiopathic gastroparesis, gastroesophageal reflux disease, pyloric stenosis or obstruction, intestinal obstruction; severe chronic gastrointestinal disease (e.g., active ulcer, intestinal tuberculosis within 6 months prior to screening); history of frequent nausea, vomiting, or irregular gastrointestinal motility from any cause (e.g., habitual diarrhea, habitual constipation, inflammatory bowel disease, irritable bowel syndrome); or long-term use of medications directly affecting gastrointestinal motility.

12.Recent abdominal surgery or history of major abdominal surgery. 13.Thyroid dysfunction or other endocrine diseases affecting glucose metabolism (Cushing's syndrome, acromegaly, pheochromocytoma, prolactinoma, etc.), except stable treated hypothyroidism (for 3 months) or subclinical hypothyroidism not requiring treatment.

14.History of malignancy within 5 years prior to screening, or current malignancy.

15.History of tuberculosis or current use of anti-tuberculosis medications. 16.Current use of antipsychotic agents, alcohol abuse, or drug dependence. 17.Current use of thiazide diuretics, beta-blockers, nicotinic acid for lipid-lowering, systemic glucocorticoids, or weight-loss medications.

18.Known hypersensitivity to Chiglitazar Sodium or its components. 19.Pregnancy or breastfeeding. 20.Unexplained weight loss > 10% of baseline body weight within 6 months prior to screening.

21.Participation in another clinical trial within 3 months prior to screening. 22.Any other condition that, in the investigator's judgment, would preclude the participant from completing the study or pose significant risk to the participant.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Chiglitazar Sodium + Lifestyle Intervention
Participants will receive Chiglitazar Sodium 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks.
药品：Chiglitazar sodium
Chiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.
安慰剂比较：Placebo + Lifestyle Intervention
Participants will receive matching placebo (Chiglitazar Sodium simulation tablet) 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks.
药品：Placebo
Matching placebo (Chiglitazar Sodium simulation tablet), 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Reversion Rate to Normal Glucose Metabolism
大体时间：Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

次要结果测量

结果测量
措施说明
大体时间
Reversion Rate to Normal Glucose Metabolism
大体时间：Week 24, Week 52
Proportion of participants achieving reversion to normal glucose metabolism at week 24 and week 52.
Week 24, Week 52
Progression Rate to Type 2 Diabetes
大体时间：Week 24, Week 52, Week 64
Proportion of participants progressing to type 2 diabetes at week 24, week 52, and week 64.
Week 24, Week 52, Week 64
Change From Baseline in Fasting Plasma Glucose (FPG)
大体时间：Week 24, Week 52, Week 64
Change from baseline in fasting plasma glucose level.
Week 24, Week 52, Week 64
Change From Baseline in OGTT 1-hour and 2-hour Postprandial Glucose (PPG)
大体时间：Week 24, Week 52, Week 64
Change from baseline in plasma glucose at 1 hour and 2 hours during oral glucose tolerance test.
Week 24, Week 52, Week 64
Change From Baseline in HbA1c
大体时间：Week 24, Week 52, Week 64
Change from baseline in glycated hemoglobin level
Week 24, Week 52, Week 64
Change From Baseline in Lipid Profile
大体时间：Week 24, Week 52, Week 64
Change from baseline in triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Week 24, Week 52, Week 64
Change From Baseline in Blood Pressure
大体时间：Week 24, Week 52, Week 64
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Week 24, Week 52, Week 64
Change From Baseline in UACR
大体时间：Week 24, Week 52, Week 64
Change from baseline in urinary albumin-to-creatinine ratio
Week 24, Week 52, Week 64
Change From Baseline in HOMA-IR
大体时间：Week 24, Week 52, Week 64
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Week 24, Week 52, Week 64
Change From Baseline in HOMA-β
大体时间：Week 24, Week 52, Week 64
Change from baseline in Homeostatic Model Assessment of β-cell function (HOMA-β).
Week 24, Week 52, Week 64
Change From Baseline in Body Weight
大体时间：Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
大体时间：Week 24, Week 52, Week 64
Change from baseline in body mass index (BMI).
Week 24, Week 52, Week 64
Change From Baseline in Waist-to-Height Ratio
大体时间：Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

其他结果措施

结果测量
措施说明
大体时间
Change From Baseline in Inflammatory Markers
大体时间：Week 24, Week 52, Week 64
Change from baseline in high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α).
Week 24, Week 52, Week 64
Incidence of Composite Cardiovascular Event
大体时间：Week 104, Week 156
Incidence of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or heart failure throughout.
Week 104, Week 156
Incidence of All-Cause Death
大体时间：Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Throughout the study (up to week 156)
Overall incidence of treatment-emergent adverse events and serious adverse events throughout the study.
Throughout the study (up to week 156)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Xiangya Hospital of Central South University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月18日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年4月22日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PRECISE trial

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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